Pharmaceutical Quality (Industry)
1.0.0 - STU1
Pharmaceutical Quality (Industry)
1.0.0 - STU1
Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions
| Active as of 2026-05-10 |
<PlanDefinition xmlns="http://hl7.org/fhir">
<id value="plandefinition-drug-pq-ex1-validation-protocol"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml">
<table class="narrative-table">
<tbody>
<tr>
<th colspan="2" scope="row" class="row-header">Metadata</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">DP PROCESS VALIDATION</td>
</tr>
<tr>
<th scope="row" class="row-header">Version</th>
<td class="content-container">1.0.0</td>
</tr>
<tr>
<th scope="row" class="row-header">Identifier</th>
<td class="content-container">urn:oid:2.16.840.1.113883.4.642.40.41.34.1</td>
</tr>
<tr>
<th scope="row" class="row-header">Subject Type</th>
<td class="content-container"><a href="MedicinalProductDefinition-medicinalproductdefinition-drug-product-pq-ex1.html">MedicinalProductDefinition: identifier = http://example.org/identifiers/product#PROD-12345; combinedPharmaceuticalDoseForm = Tablet; route = Oral use</a></td>
</tr>
<tr>
<th scope="row" class="row-header">Jurisdiction</th>
<td class="content-container">
World
</td>
</tr>
<tr>
<th scope="row" class="row-header">Steward (Publisher)</th>
<td class="content-container">HL7 International / Biomedical Research and Regulation</td>
</tr>
<tr>
<th scope="row" class="row-header">Steward Contact</th>
<td class="content-container">HL7 International / Biomedical Research and Regulation</td>
</tr>
<tr>
<th scope="row" class="row-header">Description</th>
<td class="content-container"><div><p>Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies...</p>
</div></td>
</tr>
<tr>
<th scope="row" class="row-header">Type</th>
<td class="content-container">
Workflow Definition
Process Validation
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Formulation Buffer Preparation Process Parameter Step</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Formulation Buffer Preparation Process Parameter Step
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step)</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Formulation Buffer Preparation Process Parameter Step</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">FormulationBufferPreparationProcessParameterStep
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Conclusion
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Formulation Buffer Preparation Performance Indicator Results</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">
Formulation Buffer Preparation Performance Indicator Results
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Performance Indicator Results)</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">???</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">???
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: ???)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/fc17b5d6-9fe1-91c2-2d16-47cb5b295e72</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: ???)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64525a3c-5034-448a-9c19-938ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: ???)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c19-939ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: ???)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: ???)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Thawing and Formulation Process Parameter Results</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">
Thawing and Formulation Process Parameter Resultss
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Thawing and Formulation Process Parameter Results)</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">???</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">???
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: ???)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/74515a3c-5034-448a-9c19-938ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: ???)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe2-91c2-2d16-47cb5b295e72</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: ???)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: ???)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/fc27b5d5-9fe1-92c2-2d06-47cb5b295e73</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Thawing and Formulation Performance Indicator Results</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">
Thawing and Formulation Performance Indicator Results
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Thawing and Formulation Performance Indicator Results)</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">???</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">???
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: ???)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-47cb5b295e72</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: ???)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64515a3c-5034-448a-9c19-938ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: ???)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/74515a3c-5134-448a-9c19-939ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: ???)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64515b4c-5134-448a-9c19-949ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: ???)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958434</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Bioburden Reduction Filtration Process Parameter Results</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">
Bioburden Reduction Filtration Process Parameter Results
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Bioburden Reduction Filtration Process Parameter Results)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-949ce1958434</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Bioburden Reduction Filtration Performance Indicator Results</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">
Bioburden Reduction Filtration Performance Indicator Results
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Bioburden Reduction Filtration Performance Indicator Results)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958434</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Bioburden Reduction Filtration Performance Indicator Results)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/75515b3c-5134-448a-9c19-949ce1958434</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Media Challenge Hold Times</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">
Media Challenge Hold Times
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Media Challenge Hold Times)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Media Challenge Results</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">
Media Challenge Results
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Media Challenge Results)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Media Challenge Results)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Filtered Formulated Drug Product Performance Indicator Results</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">
Filtered Formulated Drug Product Performance Indicator Results
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Filtered Formulated Drug Product Performance Indicator Results)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Filtered Formulated Drug Product Performance Indicator Results)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64525a4d-5034-448a-9c19-938ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Filtered Formulated Drug Product Performance Indicator Results)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Fill Weight Summary</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">
Fill Weight Summary
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Fill Weight Summary)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce2958524</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Filling Homogeneity Quality Attributes</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Filling Homogeneity Quality Attributes
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Filling Homogeneity Quality Attributes)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Conclusion
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/22525a3c-5035-448a-9c19-938ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Filling Results Summary</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">
Filling Results Summary
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Filling Results Summary)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958524</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Filling Results Summary)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Statistical Evaluation of Homogeneity Data</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">
Statistical Evaluation of Homogeneity Data
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Statistical Evaluation of Homogeneity Data)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958534</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Statistical Evaluation of Homogeneity Data)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Consistency of the Lyophilization Process</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">
Consistency of the Lyophilization Process
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Consistency of the Lyophilization Process)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Consistency of the Lyophilization Process)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Definition
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ActivityDefinition/b664977d-799d-a1ce-928a-6def2a9955bd</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Lyophilization Homogeneity</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">
Lyophilization Homogeneity Results
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Lyophilization Homogeneity)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Lyophilization Homogeneity)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">Generated using version 0.5.4 of the sample-content-ig Liquid templates</th>
</tr>
</tbody>
</table>
</div>
</text>
<url
value="http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex1-validation-protocol"/>
<identifier>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:oid:2.16.840.1.113883.4.642.40.41.34.1"/>
</identifier>
<version value="1.0.0"/>
<title value="DP PROCESS VALIDATION"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/plan-definition-type"/>
<code value="workflow-definition"/>
<display value="Workflow Definition"/>
</coding>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type"/>
<code value="process-validation"/>
<display value="Process Validation"/>
</coding>
</type>
<status value="active"/>
<subjectReference>🔗
<reference
value="MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1"/>
</subjectReference>
<date value="2026-05-10T20:32:51+00:00"/>
<publisher value="HL7 International / Biomedical Research and Regulation"/>
<contact>
<name value="HL7 International / Biomedical Research and Regulation"/>
<telecom>
<system value="url"/>
<value value="http://www.hl7.org/Special/committees/rcrim"/>
</telecom>
</contact>
<description
value="Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies..."/>
<jurisdiction>
<coding>
<system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
<code value="001"/>
<display value="World"/>
</coding>
</jurisdiction>
<action>
<title value="Formulation Buffer Preparation Process Parameter Step"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code value="FormulationBufferPreparationProcessParameterStep"/>
<display
value="Formulation Buffer Preparation Process Parameter Step"/>
</coding>
<text value="Formulation Buffer Preparation Process Parameter Step"/>
</code>
<action>
<title value="Formulation Buffer Preparation Process Parameter Step"/>
<code>
<text value="FormulationBufferPreparationProcessParameterStep"/>
</code>
<action>
<code>
<text value="Conclusion"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72"/>
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<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73"/>
</action>
</action>
</action>
<action>
<title
value="Formulation Buffer Preparation Performance Indicator Results"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code value="FormulationBufferPreparationPerformanceIndicatorStep"/>
<display
value="Formulation Buffer Preparation Performance Indicator Results"/>
</coding>
</code>
<action>
<title value="???"/>
<code>
<text value="???"/>
</code>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/fc17b5d6-9fe1-91c2-2d16-47cb5b295e72"/>
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<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64525a3c-5034-448a-9c19-938ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c19-939ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958424"/>
</action>
</action>
</action>
<action>
<title value="Thawing and Formulation Process Parameter Results"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code value="ThawingandFormulationProcessParameterResultsStep"/>
<display value="Thawing and Formulation Process Parameter Resultss"/>
</coding>
</code>
<action>
<title value="???"/>
<code>
<text value="???"/>
</code>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/74515a3c-5034-448a-9c19-938ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe2-91c2-2d16-47cb5b295e72"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/fc27b5d5-9fe1-92c2-2d06-47cb5b295e73"/>
</action>
</action>
</action>
<action>
<title value="Thawing and Formulation Performance Indicator Results"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code value="ThawingandFormulationPerformanceIndicatorResultsStep"/>
<display
value="Thawing and Formulation Performance Indicator Results"/>
</coding>
</code>
<action>
<title value="???"/>
<code>
<text value="???"/>
</code>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-47cb5b295e72"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64515a3c-5034-448a-9c19-938ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/74515a3c-5134-448a-9c19-939ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64515b4c-5134-448a-9c19-949ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958434"/>
</action>
</action>
</action>
<action>
<title value="Bioburden Reduction Filtration Process Parameter Results"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code
value="BioburdenReductionFiltrationProcessParameterResultsStep"/>
<display
value="Bioburden Reduction Filtration Process Parameter Results"/>
</coding>
</code>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-949ce1958434"/>
</action>
</action>
<action>
<title
value="Bioburden Reduction Filtration Performance Indicator Results"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code
value="BioburdenReductionFiltrationPerformanceIndicatorResultsStep"/>
<display
value="Bioburden Reduction Filtration Performance Indicator Results"/>
</coding>
</code>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958434"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/75515b3c-5134-448a-9c19-949ce1958434"/>
</action>
</action>
<action>
<title value="Media Challenge Hold Times"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code value="MediaChallengeHoldTimesStep"/>
<display value="Media Challenge Hold Times"/>
</coding>
</code>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434"/>
</action>
</action>
<action>
<title value="Media Challenge Results"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code value="MediaChallengeResultsStep"/>
<display value="Media Challenge Results"/>
</coding>
</code>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524"/>
</action>
</action>
<action>
<title
value="Filtered Formulated Drug Product Performance Indicator Results"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code
value="FilteredFormulatedDrugProductPerformanceIndicatorResultsStep"/>
<display
value="Filtered Formulated Drug Product Performance Indicator Results"/>
</coding>
</code>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
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</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424"/>
</action>
</action>
<action>
<title value="Fill Weight Summary"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code value="FillWeightSummaryStep"/>
<display value="Fill Weight Summary"/>
</coding>
</code>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce2958524"/>
</action>
</action>
<action>
<title value="Filling Homogeneity Quality Attributes"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code value="FillingHomogeneityQualityAttributesStep"/>
<display value="Filling Homogeneity Quality Attributes"/>
</coding>
<text value="Filling Homogeneity Quality Attributes"/>
</code>
<action>
<code>
<text value="Conclusion"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/22525a3c-5035-448a-9c19-938ce1958424"/>
</action>
</action>
<action>
<title value="Filling Results Summary"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code value="FillingResultsSummaryStep"/>
<display value="Filling Results Summary"/>
</coding>
</code>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958524"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524"/>
</action>
</action>
<action>
<title value="Statistical Evaluation of Homogeneity Data"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code value="StatisticalEvaluationOfHomogeneityDataStep"/>
<display value="Statistical Evaluation of Homogeneity Data"/>
</coding>
</code>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958534"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524"/>
</action>
</action>
<action>
<title value="Consistency of the Lyophilization Process"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code value="ConsistencyoftheLyophilizationProcessStep"/>
<display value="Consistency of the Lyophilization Process"/>
</coding>
</code>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72"/>
</action>
<action>
<code>
<text value="Definition"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ActivityDefinition/b664977d-799d-a1ce-928a-6def2a9955bd"/>
</action>
</action>
<action>
<title value="Lyophilization Homogeneity"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code value="LyophilizationHomogeneityStep"/>
<display value="Lyophilization Homogeneity Results"/>
</coding>
</code>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424"/>
</action>
</action>
</PlanDefinition>
IG © 2023+ HL7 International / Biomedical Research and Regulation.
Package hl7.fhir.uv.pharm-quality#1.0.0 based on FHIR 5.0.0.
Generated
2026-05-10
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